Exforge 5/320mg Tablets

Exforge is a combination of two antihypertensive agents: amlodipine, a dihydropyridine calcium channel blocker (CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, leading to peripheral arterial vasodilation and reduction in peripheral vascular resistance, thereby lowering blood pressure. Valsartan selectively blocks the binding of angiotensin II to the AT1 receptor in various tissues, including vascular smooth muscle and the adrenal gland. This blockade inhibits the vasoconstrictor and aldosterone-secreting effects of angiotensin II, leading to vasodilation, decreased aldosterone secretion, and reduced sodium and water reabsorption, resulting in blood pressure reduction.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high potassium levels, such as:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Severe dizziness or fainting
New or worsening chest pain
Swelling in the arms or legs
Stiff muscles, shakiness, or abnormal muscle movements

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor:

Dizziness
Nose or throat irritation
* Signs of a common cold

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
If you have kidney disease, as this may affect how your body processes the medication.
If you are taking a medication that contains aliskiren, particularly if you have diabetes or kidney problems, as this combination may increase your risk of adverse effects.
If you are breastfeeding, as you should not breastfeed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications. Never start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, be cautious when driving or performing tasks that require alertness, as it may affect your ability to do so. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and exercise caution when navigating stairs.

Regularly monitor your blood pressure as directed by your healthcare provider. Additionally, adhere to the schedule for blood work and other laboratory tests as recommended by your doctor.

Be aware that this medication may rarely cause new or worsening chest pain, which can increase the risk of a heart attack, particularly in individuals with severe heart blood vessel disease. Discuss this risk with your doctor.

Before using any over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products, consult with your doctor.

If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor. Similarly, if you are on a low-salt or salt-free diet, discuss this with your doctor.

It may take several weeks to experience the full effects of this medication. Before consuming alcohol, consult with your doctor.

In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, notify your doctor, as these symptoms may lead to low blood pressure.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

• Aliskiren (in patients with diabetes or renal impairment (GFR <60 mL/min/1.73m²))
• Sacubitril/valsartan (Entresto) - concomitant use with ARBs is contraindicated due to increased risk of angioedema.

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) or potassium supplements (increased risk of hyperkalemia)
• Lithium (increased serum lithium concentrations and toxicity)
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin) - may increase amlodipine exposure, leading to increased risk of hypotension and edema.
• CYP3A4 inducers (e.g., rifampin, St. John's Wort) - may decrease amlodipine exposure, leading to reduced efficacy.
• NSAIDs (including selective COX-2 inhibitors) - may attenuate the antihypertensive effect of valsartan and increase the risk of renal impairment.
• Other antihypertensive agents (additive hypotensive effect)

• Simvastatin (amlodipine may increase simvastatin exposure; limit simvastatin dose to 20 mg daily)
• Grapefruit juice (may increase amlodipine exposure)
• Dantrolene (IV) - risk of hyperkalemia and cardiovascular depression with amlodipine.

• Not specifically identified as minor for this combination, but general caution with other medications affecting blood pressure.

• Dizziness or lightheadedness (especially upon standing)
• Peripheral edema (swelling of ankles/feet)
• Headache
• Flushing
• Fatigue
• Palpitations
• Shortness of breath
• Unusual weight gain
• Signs of angioedema (swelling of face, lips, tongue, throat)

Contraindicated during the second and third trimesters of pregnancy due to the risk of fetal injury and death associated with the valsartan (ARB) component. Discontinue as soon as pregnancy is detected. First trimester exposure risk is less clear but generally avoided.

Not recommended during breastfeeding. Both amlodipine and valsartan are excreted in animal milk, and it is unknown if they are excreted in human milk. Due to the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended.

No overall differences in effectiveness or safety were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and titrate slowly, monitoring renal function and blood pressure closely due to increased likelihood of decreased renal function and polypharmacy.

• Exforge is a fixed-dose combination and is generally not recommended for initial therapy of hypertension, but rather for patients whose blood pressure is not adequately controlled on monotherapy with amlodipine or valsartan, or for initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
• Monitor for peripheral edema, a common side effect of amlodipine, which may be less pronounced with the combination due to valsartan's vasodilatory effects.
• Educate patients about the risk of hyperkalemia, especially if they are also taking potassium supplements, potassium-sparing diuretics, or other medications that increase potassium.
• Emphasize the critical importance of avoiding use during pregnancy due to the black box warning for fetal toxicity.
• Take consistently at the same time each day, with or without food.

• Other Angiotensin Receptor Blockers (ARBs) (e.g., Losartan, Irbesartan)
• Other Calcium Channel Blockers (CCBs) (e.g., Nifedipine, Felodipine)
• ACE Inhibitors (ACEIs) (e.g., Lisinopril, Ramipril)
• Thiazide Diuretics (e.g., Hydrochlorothiazide, Chlorthalidone)
• Beta-blockers (e.g., Metoprolol, Carvedilol)
• Alpha-blockers (e.g., Doxazosin, Terazosin)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.